Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH

DRUGSTORE ( ) / HOSPITAL PHARMACY ( ) / INSTITUTIONAL PHARMACY ( )
SELF-ASSESSMENT TOOLKIT FORM
INITIAL APPLICATION OF LICENSE TO OPERATE
COMPANY NAME : PHARMAZING PHARMACY
COMPANY ADDRESS : LIDLIDDA, GREEN MARKET BLDG., SUYSUYAN, LIDLIDDA, ILOCOS
SUR
OWNER : ROLANDO E. CABANGCALA
ACTIVITY : RETAILING NON-STERILE OMPOUNDING
STERILE COMPOUNDING ONLINE ORDERING AND DELIVERY
MOBILE PHARMACY

Directions:
Fill out the form by ticking the applicable box. Provide remarks on the client’s column when necessary. Submit in
Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.
REMARKS
DOCUMENTARY REQUIREMENTS: Yes No
CLIENT FDA
1. Application Form
 Is the integrated application form properly filled out?            
 Is it duly notarized?            
 Are the signatories in the application form the authorized
persons as required under the following circumstances?
(a) If single proprietorship – the owner as registered in DTI            
(unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators or            
authorized person as indicated in the board resolution or
Secretary’s Certificate
(c) If cooperative – authorized person indicated in the board            
resolution or Secretary’s Certificate of the cooperative
If the signatory is not the owner or one of the incorporators, as
the case may be:
 Is there a board resolution or notarized Secretary’s N/A      
Certificate clearly identifying the person authorized to sign
for and in behalf of the owner or corporation submitted?
For government-owned establishments:
 Is there an Order (or equivalent document) identifying the N/A      
person authorized to sign for and in behalf of the
establishment submitted?

2. Proof of Business Name Registration

(a) For single proprietorship, Certificate of Business
Registration issued by the Department of Trade and
Industry (DTI)
 Is the business name applied for LTO the same with that of
DTI registration certificate?
           
Note: If franchisee, the business name of the franchisor shall
be used.
 Is the DTI certificate still valid?            
 Is the owner appearing in the application form the same with
           
that of the DTI certificate?

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 Is the address of the establishment applying for LTO within
the territorial coverage? If the business address indicated in
DTI is different from the exact address as declared in the            
application form, is there a clear copy of Business/Mayor’s
Permit or Barangay clearance indicating the complete
address of drug establishment?
(b) For corporation, partnership and other juridical person,
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of
Incorporation
 Is the business name applied for LTO the same with that of N/A      
the SEC registration certificate? If the company uses another
business name style different from its corporate name, is an
amended SEC registration reflecting the same submitted?
 Is the address indicated in the SEC the same with the address N/A      
of the establishment applied for LTO?
o If the address in SEC is still occupied but the N/A      
business operation applied for LTO is located
in a separate area, is a clear scanned copy of
Business /Mayor’s Permit or Barangay
clearance indicating the complete address of
drug establishment submitted?
o If the address in SEC is no longer occupied, is N/A      
an amended SEC registration reflecting the
current business address submitted?
 Is the type of activity and product applied for LTO indicated N/A      
in the Articles of Incorporation (Article II)?
(c) For cooperative, Certificate of Registration issued by the
Cooperative Development Authority and the approved
by-laws
 Is the business name applied for LTO the same with that of N/A      
the CDA registration certificate?
 Is the address indicated in the CDA the same with the address N/A      
of the establishment applied for LTO?
 Is the type of activity and product applied for LTO indicated N/A      
in the approved articles and by-laws of the cooperative?
(d) For government-owned or controlled corporation
 Is there a copy of the law creating the same? (if with original
charter)
Note: If the drugstore is not owned by the government, certificate N/A      
of business name registration shall follow the requirements
under 2.a,b,c (where applicable).

3. Credentials of Pharmacist and Responsible Pharmacy Assistant

 Is the responsible pharmacist identified? MA. ESTRELLA
     
Identify the name under client’s remarks: ANN B. SANTIAGO
 Is the PRC ID of the responsible pharmacist still valid?
           

 If the PRC is not valid, is there a proof of renewal attached? N/A      

 Is the resignation letter of the responsible pharmacist from

previous company signed/ conformed by the owner/authorized            
representative of the establishment? (where applicable)
 Is the LTO number of the previous company
           
indicated?
 Is the name of pharmacist in the certificate of attendance to
FDA seminar on licensing of establishment the same with            
application form for LTO?
 Is the seminar attended corresponds to the type of LTO
           
applied by the establishment?

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 If not yet attended, is any proof of confirmation issued by the
N/A      
FDA Academy of the scheduled licensing seminar included?
 Is the pharmacy assistant/s identified?
           
Identify the name under client’s remarks:
 If a pharmacy assistant is employed, is a copy of Pharmacy
Services National Certification (NC) III issued by TESDA            
submitted?
 If there is no (NC) III certificate provided, is there a
certificate of attendance to the PA Summit or proof of            
registration of the summit submitted?

4. Risk Management Plan

 Are the risks for the establishment properly identified?            
 Are there plans of action for these identified risks?            
 Is there an established SOP for pharmacovigilance?            
 Is there an established SOP for handling regulatory mandates
from FDA, such as product recall, withdrawal, suspension of            
activities, etc?
Note: While the official RMP framework from FDA is not yet
issued, a commitment letter must be submitted.

5. Location Plan
 Is the sketch submitted indicates certain landmark?            
 Is the Global Positioning System (GPS) Coordinates            
included?

6. Picture of Drugstore with Display of Signage

 Does the picture clearly show the signage bearing the exact
business name of the establishment as registered in DTI/SEC            
(except for franchise drugstore)
 If the signage does not bear the exact business name of the
establishment as registered in DTI/SEC, is there a
N/A      
certificate/document from the Intellectual Property Office
(IPO) submitted?

7. Proof of Payment
 Is the payment made according to the required fee?            
 Is there a scanned copy of proof of payment (e.g FDA official
           
receipt, Landbank On-coll validated slip ) submitted?
NOTE: ADDITIONAL DOCUMENTS MAY BE REQUIRED TO BE SUBMITTED AS DEEMED NECESSARY.
ADDITIONAL REQUIREMENTS
(ON-SITE INSPECTION ONLY):
1. Agreement between the franchisor and franchisee, where applicable

2. Records/E-file
(a) Records of invoices containing the minimum required data such as but not limited to: name of product, complete name
& address of drug supplier, packaging size, dosage form & strength, batch/lot number, expiry date, date and quantity
received by the establishment.
(b) Prescription book or e-file to be kept for 2 years
(c) Senior citizens, PWD
(d) Menu cards (generics, MDRP, GMAP)
(e) Information, Education and Campaign (IEC) Material

3. Standard Operating Procedure

(a) Receipt and Dispatch
 Is there an orderly and secure system of filling up to date invoices from suppliers and buyers identifying lot numbers
or batch numbers of manufacturers stock pursuant to FDA Memo Circular No. 001 s. 1983? Is there a product description,
expiry date and transport temperature?
(b) Handling of consumer complaints, product recalls, and other regulatory mandates

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 Does the establishment maintain registry of complaint with action?
(c) Disposal of expired/deteriorated/ damaged and returned products
(d) Cleaning of Storage Area
 Is there a regular conduct of pest control?
(e) Other SOPs as required

4. Display of Information, Education, and Communication Materials as required

5. If with additional activity:
(a) Certificate of Training of the Pharmacist
(b) Documents related to the additional activity with proof of validation

6. Reference Materials
(a) R.A. 3720, R.A 9711, R.A. 6675, R.A. 5921, R.A. 8203, R.A. 9502
(b) WHO Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 Guide to Good
Storage Practices for Pharmaceuticals
(c) Philippine National Drug Formulary
(d) Standard Practice Guidelines (Phil. PSP)
(e) Pharmacovigilance-related References
(f) Other applicable reference materials, including latest issuance of FDA related to community practice
--- To be filled out by client: ---
Prepared by: MA. ESTRELLA ANN B. Signature:      
SANTIAGO
Position (Pharmacist / Owner): PHARMACIST Date:      
--- To be filled out by RFO: ---
Decision: Remarks:      
Approval
Denial
Clarification
Inspection Evaluated by: Date:
           
           
--- To be filled out by CDRR: ---
Decision: Remarks:      
Approval
Clarification
Evaluated by: Date: